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BRISBANE, Calif. - Vera Therapeutics, Inc. (NASDAQ:VERA) announced today that its ORIGIN Phase 3 trial for atacicept, a treatment for immunoglobulin A nephropathy (IgAN), met its primary endpoint. The trial demonstrated a 46% reduction in proteinuria from baseline and a 42% reduction compared to placebo at week 36 (p
The study also reported favorable safety outcomes, with atacicept’s safety profile comparable to that of the placebo. These results, consistent with or better than those from the Phase 2b trial, signal a potential advance in the standard of care for IgAN, a chronic kidney disease with limited treatment options. While the stock has experienced a 62% decline over the past six months, analysts maintain optimistic price targets ranging from $26 to $100, suggesting significant potential upside. InvestingPro subscribers can access additional insights and detailed financial metrics to better evaluate the investment opportunity.
Vera Therapeutics plans to discuss these findings with the FDA in the coming weeks, aiming to submit a Biologics License Application (BLA) for accelerated approval in the fourth quarter of 2025. The ORIGIN 3 trial is ongoing, with two-year results expected in 2027.
Atacicept is a recombinant fusion protein that targets cytokines involved in B-cell activation, which is associated with autoimmune diseases like IgAN. The therapy has previously received FDA Breakthrough Therapy Designation, reflecting its potential to substantially improve treatment over existing therapies.
The press release statement also highlighted the significant impact of IgAN on patients’ quality of life and mental wellbeing, underscoring the importance of developing new treatments. Vera Therapeutics is committed to evolving kidney medicine and potentially expanding atacicept’s use to other autoimmune kidney diseases.
The company will host an investor call and webcast to discuss the data update. The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study involving 431 adults with IgAN. Participants self-administer atacicept or placebo via subcutaneous injection once weekly, with the primary efficacy endpoint being the change in 24-hour urine protein-to-creatinine ratio (UPCR) at the 36-week interim analysis. With a market capitalization of $1.2 billion and a strong current ratio of 27.68, InvestingPro analysis indicates the company has ample liquidity to support its ongoing clinical programs.
The information in this article is based on a press release statement from Vera Therapeutics.
In other recent news, Vera Therapeutics reported a larger-than-expected loss for the first quarter of 2025, with a net loss of $0.81 per share, exceeding analyst estimates of a $0.73 per share loss. The company’s net loss increased to $51.7 million, up from $28.4 million in the same period last year. Despite this, Vera Therapeutics emphasized progress in its lead program, atacicept, aimed at treating IgA Nephropathy (IgAN). The company is preparing to announce pivotal Phase 3 ORIGIN trial results in the second quarter of 2025 and plans to submit a Biologics License Application to the U.S. FDA later that year. Cantor Fitzgerald maintained its Overweight rating on Vera Therapeutics, with a price target of $100, noting the firm’s potential in the IgAN treatment landscape. Analysts from Cantor Fitzgerald have labeled Vera Therapeutics a "Top Pick," highlighting the anticipation surrounding the upcoming trial data. Additionally, Vera Therapeutics announced an expanded development program for atacicept in other autoimmune kidney diseases. The company reported having $589.8 million in cash and securities as of March 31, 2025, which is expected to support operations through the potential approval and U.S. commercial launch of atacicept.
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